Highlights of the EMA’s human medicine committee meeting, April 2021
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The Committee for Medicinal Products for Human Use (CHMP) recommended eight drugs for approval and nine indication extensions.
The European Medicines Agency (EMA) has recently announced the results of its April 2021 Committee for Medicinal Products for Human Use (CHMP) Meeting. In the meeting, the committee recommended eight new medicines for approval, including two orphan drugs, taking the total granted positive opinions this year to 34.
Recommended for approval
The committee granted its positive opinion to
Enspryng (satralizumab), an orphan drug for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive. See more details in the news announcement in the grid below. NMOSD is a rare and life-threatening condition affecting the optic nerves and spinal cord. The disorder, thought to be caused by the immune system